Senior Manager, Global Regulatory Sciences, Oncology- UK and Ireland

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us

Responsible for all regulatory activities related to assigned products in the role as Senior Manager, Global Regulatory Sciences, UK and Ireland:

• Implement the regulatory vision and provide high quality, strategic leadership in executing Regulatory activities in the UK and Ireland.
• Drive regulatory processes in line with business and Research & Development and Commercial objectives.
• Mentors junior staff.

Key Responsibilities, not limited to:

• Represents UKI on the Global Regulatory Teams for assigned registrational and lifecycle management products and ensures that the UKI requirements are reflected in the Global Regulatory Plans and registration dossiers.
• Reviews, evaluates, prepares and files nonclinical, clinical and/or quality dossiers and related documentation to Regulatory Agencies in UK and Ireland.
• Conducts critical review of documents related to clinical, drug safety, nonclinical or manufacturing, as necessary to identify and communicate potential risks and mitigations associated with regulatory strategies to local and global stakeholders.
• Critically reviews/assesses MHRA requests and decisions as well responses prepared by cross-functional Global Teams, data packages, guidance documents and local/global regulatory environment and provides Global Team with appropriate strategic feedback to ensure optimal response strategies/outcomes.
• Responsible for driving regulatory strategy and processes in line with business/R&D objectives to support timely registration of new products/line extensions and variation applications of BMS products.
• Acts as Local Health Authority Liaison with the Regulatory Agencies in UK and Ireland for assigned products and topics.
• Responsible for assuring that approved labelling text (SmPC, PIL, packaging label text) is implemented in production in accordance with local legislation.
• Responsible for the review and approval of Prescribing Information (PI) in UK and Ireland
• Responsible for supporting and filing clinical trial applications to the competent regulatory authorities in UK and Ireland, and all following interactions.
• Act as a key partner for the UK/Ireland Affiliate functions i.e., Medical, Regional Clinical Operations, Marketing, Market Access, Patient Safety, Quality and Logistics etc. and Global Regulatory.
• Drive and support local/global projects and department related assignments.
• To keep up to date with Regulatory Intelligence i.e., policy, Health Authority guidance, product competitive intelligence etc.

Skills and Experience

• University degree, ideally a Master of Science degree, preferably in medical, pharmaceutical, or other life sciences or the equivalent in relevant work experience
• 3+ years of experience in regulatory activities, including marketing authorisation and clinical trial submissions, life-cycle management activities, pre-launch and launch activities support and health authority interactions in the UK and Ireland
• Thorough knowledge of EU and local (UK and Ireland) regulatory processes
• Knowledge of Good Practices (GMP, GDP, GCP) and quality systems used during stages of manufacture, testing, release, transportations and storage of medicinal products
• Experience in supporting and working with regulatory affairs staff on a full range of regulatory tasks.
• Demonstrated ability in planning, problem solving and time management
• Demonstrated ability in working in a matrix organisation and influencing of people in cross-functional teams
• Ability of independent scientific thought, and the capacity to learn and understand new scientific concepts and ideas

Responsible for all regulatory activities related to assigned products in the role as Senior Manager, Global Regulatory Sciences, UK and Ireland:

• Implement the regulatory vision and provide high quality, strategic leadership in executing Regulatory activities in the UK and Ireland.
• Drive regulatory processes in line with business and Research & Development and Commercial objectives.
• Mentors junior staff

Key Responsibilities, not limited to:

• Represents UKI on the Global Regulatory Teams for assigned registrational and lifecycle management products and ensures that the UKI requirements are reflected in the Global Regulatory Plans and registration dossiers.
• Reviews, evaluates, prepares and files nonclinical, clinical and/or quality dossiers and related documentation to Regulatory Agencies in UK and Ireland.
• Conducts critical review of documents related to clinical, drug safety, nonclinical or manufacturing, as necessary to identify and communicate potential risks and mitigations associated with regulatory strategies to local and global stakeholders.
• Critically reviews/assesses MHRA requests and decisions as well responses prepared by cross-functional Global Teams, data packages, guidance documents and local/global regulatory environment and provides Global Team with appropriate strategic feedback to ensure optimal response strategies/outcomes.
• Responsible for driving regulatory strategy and processes in line with business/R&D objectives to support timely registration of new products/line extensions and variation applications of BMS products.
• Acts as Local Health Authority Liaison with the Regulatory Agencies in UK and Ireland for assigned products and topics.
• Responsible for assuring that approved labelling text (SmPC, PIL, packaging label text) is implemented in production in accordance with local legislation.
• Responsible for the review and approval of Prescribing Information (PI) in UK and Ireland
• Responsible for supporting and filing clinical trial applications to the competent regulatory authorities in UK and Ireland, and all following interactions.
• Act as a key partner for the UK/Ireland Affiliate functions i.e., Medical, Regional Clinical Operations, Marketing, Market Access, Patient Safety, Quality and Logistics etc. and Global Regulatory.
• Drive and support local/global projects and department related assignments.
• To keep up to date with Regulatory Intelligence i.e., policy, Health Authority guidance, product competitive intelligence etc